In our day jobs we help companies comply with FDA regulations. Frequently, however, we find that the underlying cause of poor compliance performance is a lack of understanding of the basic technology of their manufacturing process. But beneath even that often lies a more fundamental challenge that many organizations struggle with: how to help technical personnel to improve people management skills. In this blog we will touch on some of the non-technical aspects of compliance management.
My business partner, Nicole, has one of the quickest minds in our business, quality consulting for drugs and medical devices. But I’m blown away at her response to the revelation that confronted her during a recent audit.